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Industry has been lobbying for changes they argue will improve care for patients and open new business opportunities. The American Hospital Association, American Medical Association and AdvaMed each submitted feedback when the administration requested ideas on how to alter the Anti-Kickback Statute and Stark Law in 2018.

The effort to reform the set of laws largely fell under the stewardship of HHS Deputy Secretary Eric Hargan, who has argued over the past few years that while they were written with good intentions to prevent self-interested patient referrals by doctors, they have incentivized consolidation and impeded care in the healthcare system. …

While many of the changes will be welcomed by industry, pharmaceutical manufacturers, durable medical equipment manufacturers and suppliers, and laboratories are excluded from partaking in value-based and patient engagement arrangements, Jennifer Michael, a healthcare attorney at Epstein Becker Green who previously served as chief of the industry guidance branch at OIG, told MedTech Dive in an email. Azar told reporters HHS is still working on separate regulations that would enable value-based outcome payments for pharmaceutical products, and aims to get changes out “as soon as possible.”

“The breadth and scope of the proposed new safe harbors is remarkable; unlike OIG's previously issued safe harbors, if finalized, they would protect arrangements of unknown design and unproven efficacy as long as the parties reasonably anticipate the arrangement will advance the coordination and management of care of a target patient population and the arrangement satisfies all of a safe harbor's other requirements,” Michael said.

But notably, she added, OIG said in its proposed rule any final safe harbors will only give prospective protection. The proposed rule notes that emerging payment models might present risks that haven't been identified by OIG or the broader healthcare industry.